Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196206

CV010-018

Details and patient eligibility

About

Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
• Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
• Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
• Females must be of non-childbearing potential

Exclusion criteria

• Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
• Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant

Other protocol defined inclusion and exclusion criteria could apply

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group A

Experimental group

Description:

Normal Renal Function

Treatment:

Drug: BMS-986177

Group B

Experimental group

Description:

Moderate Renal Impairment

Treatment:

Drug: BMS-986177

Group C

Experimental group

Description:

Severe Renal Impairment

Treatment:

Drug: BMS-986177